Department of Obstetrics and Gynecology.
Institute of Biostatistics and Analyses, Masaryk University Medical School, Brno, Czech Republic.
Urogynecology (Phila). 2023 Feb 1;29(2):113-120. doi: 10.1097/SPV.0000000000001284.
This study compares the long-term efficacy and safety of an innovative single-incision sling (SIS) with the inside-out transobturator tape (TOT) sling in the treatment of female stress urinary incontinence.
Women with urodynamic stress urinary incontinence were randomized to either SIS or TOT groups and followed up for 4 years. The primary outcome was objective cure defined with a negative cough stress test result. Secondary outcomes involved subjective cure reported via patient's satisfaction scale, surgery complications, postoperative de novo urgency, and patient's life quality.
This is a randomized noninferiority controlled trial.
A total of 168 women were randomized (84 in both groups). After 4-year follow-up, 130 patients were analyzed (66 in the SIS group and 64 in the TOT group). The objective (86.4% vs 84.4%; risk difference [95% confidence interval], 0.020 [-0.101 to 0.141]; P = 0.807) and subjective cure rates (83.3% vs 81.3%; risk difference [95% confidence interval], 0.020 [-0.111 to 0.151]; P = 0.821) were similar with the SIS and TOT groups. Both procedures were associated with low complication rates. Repeated surgery rates were 7.6% in the SIS group and 6.3% in the TOT groups. The mesh exposure rate was 1.5% for the SIS group and 3.1% for the TOT group. Incidence of de novo urgency did not vary between TOT and SIS patients. Both groups registered significant life quality improvement.
After long-term follow-up, anti-incontinence SIS surgery proved noninferior to the inside-out TOT procedure in terms of objective and subjective cure rates.
本研究比较了一种创新的单切口吊带（SIS）与经阴道内闭孔吊带（TOT）治疗女性压力性尿失禁的长期疗效和安全性。
将尿动力学压力性尿失禁女性患者随机分为 SIS 或 TOT 组，并随访 4 年。主要结局是通过咳嗽应激试验阴性结果定义的客观治愈率。次要结局包括患者满意度评分、手术并发症、术后新发尿急和患者生活质量报告的主观治愈率。
这是一项随机非劣效性对照试验。
共有 168 名女性被随机分为两组（每组 84 名）。经过 4 年的随访，对 130 名患者进行了分析（SIS 组 66 名，TOT 组 64 名）。客观（86.4% vs 84.4%；风险差异[95%置信区间]，0.020[-0.101 至 0.141]；P=0.807）和主观治愈率（83.3% vs 81.3%；风险差异[95%置信区间]，0.020[-0.111 至 0.151]；P=0.821）在 SIS 和 TOT 组之间相似。两种手术都与低并发症发生率相关。SIS 组重复手术率为 7.6%，TOT 组为 6.3%。SIS 组的网片暴露率为 1.5%，TOT 组为 3.1%。TOT 和 SIS 患者新发尿急的发生率没有差异。两组患者的生活质量均显著改善。
长期随访后，抗失禁 SIS 手术在客观和主观治愈率方面被证明不劣于经阴道内闭孔 TOT 手术。
